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CAR T-cell Therapy

Siltuximab + Epcoritamab for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Led By Paolo F Caimi, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For men: agreement to remain abstinent or use contraceptive measures and refrain from donating sperm

Diagnosis of non-Hodgkin lymphoma

Must not have

Primary mediastinal B cell lymphoma

Uncontrolled intercurrent illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days beginning treatment

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test if giving siltuximab before epcoritamab can make it safer and more effective in treating large B-cell lymphoma or follicular lymphoma. Participants

Who is the study for?

This trial is for individuals with large B-cell lymphoma or follicular lymphoma. Participants must be eligible to receive epcoritamab and are willing to be monitored for at least 60 days after treatment. Specific inclusion and exclusion criteria details were not provided.

What is being tested?

The study tests if siltuximab can prevent or treat cytokine release syndrome and neurotoxicity in patients receiving epcoritamab injections, over cycles of 28 days for one year.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response (cytokine release syndrome), neurological issues, infusion-related reactions, and any other complications associated with siltuximab or epcoritamab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to not have unprotected sex or donate sperm.

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I have been diagnosed with non-Hodgkin lymphoma.

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I have Follicular Lymphoma (grades 1-3A) and have been treated with at least one cancer therapy including an anti-CD20 drug.

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My blood tests show normal levels of hemoglobin, neutrophils, and platelets.

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I have DLBCL and have been treated with a therapy that includes an anti-CD20 drug.

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I can care for myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is primary mediastinal B cell lymphoma.

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I do not have any uncontrolled illnesses.

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My lymphoma has spread to my brain or its coverings.

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I have had severe allergic reactions to specific cancer treatments.

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I have not had an infection needing treatment in the last 2 weeks.

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I have cancer other than non-melanoma skin cancer or carcinoma in situ.

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I am HIV positive.

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I have a current or past brain condition that affects my health.

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I have an active chronic hepatitis B, C, or CMV infection needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days beginning treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days beginning treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days beginning treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of all-grade cytokine release syndrome

Secondary study objectives

Best overall and complete response rates

Incidence of adverse events during Cycle 1 (Day 1 - 28)

Incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prophylactic siltuximab + epcoritamabExperimental Treatment2 Interventions

Siltuximab Administration: • Participants will receive a single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. There is no planned dose escalation of siltuximab and epcoritamab dosing will be done following the standard planned ramp-up over the course of the first 3 weeks Epcoritamab Infusion: • The treatment regimen of epcoritamab is done in 28-day cycles. Epcoritamab is to be administered by subcutaneous injection. Participants can be treated for up to 24 cycles. Participants who achieve complete remission at the time of their disease response assessment after 12 cycles may be considered for early discontinuation of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Siltuximab

2011

Completed Phase 3

~1190

0 / 15Eligibility criteria met